IMMUNE RESPONSES IN ACUTE HEPATITIS C INFECTION

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 该项目的目标是确定最近（9个月内）感染丙型肝炎病毒的受试者，并研究免疫系统处于反应的最早阶段。 采集期持续3年（每年10例研究受试者，当地）。 将从全国各地的研究中心共招募100名受试者。 检查结果证实近期感染的筛选受试者将收到关于HCV感染和治疗方案的文献，并将被转介至研究以获得知情同意（如果他们选择）。 受试者选择治疗或拒绝治疗的选择不会影响其参与研究 将对研究受试者进行为期一年的随访，在基线、2、4、6和12个月时采集1品脱血液。 将进行9个月访视，抽取6管血液，2管用于血浆病毒载量分析，2管用于T细胞分析，1管用于肝功能分析，1管用于监测白色血细胞变化。 每次访视时，将通过ALT、AST和总胆红素监测肝功能。 将进行全血细胞计数，以提供关于病毒发展期间白色血细胞计数和白细胞变化的信息。 将在基线、6个月和12个月时自行填写与生活方式和风险因素相关的问卷。 将在6个月和12个月时询问有关HCV治疗的问题。 从问卷中收集的答案将使我们能够将风险因素（例如，重复暴露）与感染结果相匹配。 此外，当我们检查个体免疫应答时，了解抗病毒治疗选择也很重要。 为了成功随访受试者一整年，将在门诊访视之间进行电话访视。 这些电话将确认联系信息并记录与研究相关的任何不良事件。 HCV的急性期在识别人类受试者方面造成了特殊的问题，因为感染的症状很少提醒护理人员病毒的存在。 HCV感染的症状通常不会出现，直到感染已经达到慢性阶段，如果他们出现在所有。 由于在临床环境中很少确定HCV急性期研究的受试者，因此本研究提供了一个独特的机会，可以在迄今为止很少检查的人群中确定和跟踪免疫应答。 自发清除感染或接受抗病毒治疗的个体的免疫应答将与免疫应答不足以解决感染的个体（慢性感染者）进行比较。 这项研究的结果将回答开发疫苗和更有效治疗丙型肝炎感染的重要问题。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The goal of the project is to identify subjects who have recently (within a 9 month period) become infected with hepatitis C virus and to study the immune system is in its earliest stages of response. The duration of the collection period will be 3 years (10 study subjects per year, locally.) A total of 100 subjects will be recruited from sites around the country. Screened subjects with test results confirming recent infection will receive literature about HCV infection, and treatment options, and will be referred to the study to be consented if they so choose. The subject's option to choose treatment or refuse treatment will not effect their participation in the study Study subjects will be followed over a one year period with a pint of blood collected at baseline, 2, 4, 6, and 12 months. There will be a 9 month visit where six tubes of blood will be drawn, two for plasma analysis for viral load, two for T-cell analysis, one for liver function analysis and one to monitor white blood cell changes. At each visit liver function will be monitored with ALT, AST, and total Bilirubin. A complete blood count will be performed to provide information about changes in white blood count and leukocytes over the period of development of the virus. Questionnaires relating to lifestyle and risk factors will be self administered at baseline, 6 and 12 months. Questions about treatment for HCV will be asked at 6 and 12 months. The answers collected from the questionnaires will allow us to match risk factors, for instance, repeated exposures, to outcome of infection. Also, it will be important to know about antiviral treatment choices as we examine the individual immune responses. In an effort to successfully follow the subject for the entire year, telephone visits will be conducted in between clinic visits. These calls will confirm contact information and capture any adverse event that is related to the study. The acute phase of HCV poses particular problems in identifying human subjects, because symptoms of the infection rarely alert care providers to the presence of the virus. Symptoms of the HCV infection generally do not appear until the infection has reached the chronic stage, if they appear at all. Since subjects for the study of the acute phase of HCV are rarely identified in a clinic setting, this study presents a unique opportunity to identify and follow immune responses in a population that has until now rarely been examined. The immune response of individuals who spontaneously clear the infection or who receive antiviral treatment will be compared to the individuals whose immune responses are inadequate to resolve the infection (those who become chronically infected.) The results of the research conducted in this study will answer the important questions vital to the development of a vaccine and more effective treatment of the hepatitis C infection.